Commission Decision of 23 March 2005 establishing ecological criteria for the award of the Community eco-label to all-purpose cleaners and cleaners for sanitary facilities (notified under document number C(2005) 1028) (Text with EEA relevance) (2005/344/EC) (repealed)

ANNEX FRAMEWORK

In order to qualify for the eco-label, an all purpose cleaner or a cleaner for sanitary facilities (hereinafter referred to as the product) must fall within the product group as defined in Article 1, and must comply with the criteria of this Annex.

The aims of the criteria

These criteria aim at promoting:

• the reduction of environmental impact by limiting the quantity of harmful ingredients, by reducing the quantity of detergent used and by reducing packaging waste,

• the reduction or prevention of risks for the environment and for human health related to the use of hazardous substances,

• information that will enable the consumer to use the product in the way that is efficient and minimises environmental impact.

The criteria are set at levels that promote the labelling of all-purpose cleaners and sanitary cleaners that have a low environmental impact.

Assessment and verification requirements

The specific assessment and verification requirements are indicated within each criterion.

Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.

Where possible, the testing should be performed by laboratories that meet the general requirements of EN ISO 17025 or equivalent

Where no tests are mentioned, or are mentioned as being for use in verification or monitoring, competent bodies should rely as appropriate on declarations and documentation provided by the applicant and/or independent verifications.

Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.

Where the applicant is required to provide declarations, documentation, analyses test reports, or other evidence to show compliance with the criteria, it is understood that these may originate from the applicant and/or his supplier(s) and/or their supplier(s), et cetera, as appropriate.

Where ingredients are referred to, this includes substances and preparations.

Appendix I presents the new revised detergent ingredient database (DID list), version 30 June 2004, which contains the most widely used ingredients in detergent formulations. Part-A of the DID list shall be used for deriving the data for the calculations of CDV_tox and for the assessment of the biodegradability of surfactants.

Where appropriate, the applicant may use subsequent revisions of the Detergent Ingredient Database as they become available.

For ingredients which are not included in part-A of the DID list, the applicant shall, under his own responsibility, apply the procedure as described in part-B of the Appendix I.

For ingredients, which are not listed in the DID-list, the applicant may use an approach to provide the necessary documentation of anaerobic degradability described in Appendix II

The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria in this Annex (Note: It is not required to implement such management schemes.)

FUNCTIONAL UNIT

For all-purpose cleaners the functional unit (used in the criteria below) is the dosage in grams of the product recommended by the manufacturer for 1 litre of suds (washing water).

For window cleaners and cleaners for sanitary facilities, no functional unit is defined (the relevant criteria below being calculated in relation to 100 g of the product).

ECOLOGICAL CRITERIA

1. Toxicity to aquatic organisms

The critical dilution volume toxicity (CDV_tox) is calculated for each ingredient (i) using the following equation:

where weight (i) is the weight of the ingredient (in grams) per functional unit (for all-purpose cleaners) or per 100 g of product (cleaners for sanitary facilities). DF (i) is the degradation factor and TF chronic (i) is the toxicity factor of the ingredient (in milligram/litre).

The values of DF and TF chronic shall be as given in the detergent ingredient database list-part A (DID list-part A) (Appendix I). If the ingredient in question is not included in the DID list-part A, the applicant shall estimate the values following the approach described in the DID list-part B (Appendix 1). The CDV_tox is summed for each ingredient, making the CDV_tox for the product.

For all-purpose cleaners, the CDV_tox for the product shall not exceed 20 000 l/functional unit.

For cleaners for sanitary facilities, the CDV_tox for the product shall not exceed 100 000 l per 100 g product.

For window cleaners, the CDV_tox for the product shall not exceed 5 000 l per 100 g product.

Assessment and verification: the exact formulation of the product shall be provided to the competent body, together with the details of the CDV_tox calculations showing compliance with this criterion.

2. Biodegradability of surfactants

(a) Ready biodegradability (aerobic)

Each surfactant used in the product shall be readily biodegradable.

Assessment and verification: the exact formulation of the product as well as a description of the function of each ingredient shall be provided to the competent body. The DID list-part A (Appendix I) indicates whether a specific surfactant is aerobically biodegradable or not (the surfactants with an entry of ‘R’ in the column on aerobic biodegradability are readily biodegradable). For surfactants which are not included in the DID list-part A, the relevant information from literature or other sources, or appropriate test results, showing that they are aerobically biodegradable shall be provided. The tests for ready biodegradability shall be as referred to in Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents(1). Surfactants shall be considered as readily biodegradable if the level of biodegradability (mineralisation) measured according to one of the five following tests is at least 60 % within 28 days: CO₂ headspace test (OECD 310), carbon dioxide (CO₂) evolution modified Sturm test (OECD 301B; Council Directive 67/548/EEC(2) Annex V.C.4-C), closed bottle test (OECD 301D; Directive 67/548/EEC Annex V.C.4-E), manometric respirometry (OECD 301F; Directive 67/548/EEC Annex V.C.4-D), or MITI (I) test (OECD 301C; Directive 67/548/EEC Annex V.C.4-F), or their equivalent ISO tests. Depending on the physical characteristics of the surfactant, one of the following tests might be used to confirm ready biodegradability, if the level of biodegradability is at least 70 % within 28 days: dissolved organic carbon DOC die-away (OECD 301A; Directive 67/548/EEC Annex V.C.4-A) or modified OECD screening DOC die-away (OECD 301E; Directive 67/548/EEC Annex V.C.4-B), or their equivalent ISO tests. The applicability of test methods based on measurement of dissolved organic carbon needs to be appropriately justified as these methods could give results on the removal and not on the biodegradability. Pre-adaptation is not to be used in tests for aerobic ready biodegradability. The 10 days window principle shall not apply.

(b) Anaerobic biodegradability

Each surfactant used in the product shall be biodegradable under anaerobic conditions.

Assessment and verification: the exact formulation of the product as well as a description of the function of each ingredient shall be provided to the competent body. The DID list-part A (Appendix I) indicates whether a specific surfactant is anaerobically biodegradable or not (the surfactants with an entry of ‘Y’ in the column on anaerobic biodegradability are biodegradable under anaerobic conditions). For surfactants which are not included in the DID list-part A, the relevant information from literature or other sources, or appropriate test results, showing that they are anaerobically biodegradable shall be provided. The reference test for anaerobic degradability shall be OECD 311, ISO 11734, ECETOC No 28 (June 1988) or an equivalent test method, with the requirement of a minimum of 60 % ultimate degradability under anaerobic conditions. Test methods simulating the conditions in a relevant anaerobic environment may also be used to document that 60 % ultimate degradability has been attained under anaerobic conditions (see Appendix II).

3. Dangerous, hazardous or toxic substances or preparations

(a) The following ingredients shall not be included in the product, either as part of the formulation or as part of any preparation included in the formulation:

• Alkyl phenol ethoxylates (APEOs) and derivatives thereof,

• EDTA (ethylene-diamine-tetra-acetate) and its salts,

• NTA (nitrilo-tri-acetate),

• Nitromusks and polycyclic musks, including for example:

  • Musk xylene: 5-tert-butyl-2,4,6-trinitro-m-xylene,

  • Musk ambrette: 4-tert-butyl-3-methoxy-2,6-dinitrotoluene,

  • Moskene: 1,1,3,3,5-pentamethyl-4,6-dinitroindan,

  • Musk tibetine: 1-tert-butyl-3,4,5-trimethyl-2,6-dinitrobenzene,

  • Musk ketone: 4’-tert-butyl-2’,6’-dimethyl-3’,5’-dinitroacetaphenone,

  • HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta(g)-2-benzopyran),

  • AHTN (6-Acetyl-1,1,2,4,4,7-hexamethyltetralin).

Assessment and verification: the applicant shall provide a declaration supported by declarations from manufacturers of ingredients, as appropriate, confirming that the listed substances have not been included in the product.

(b) Quaternary ammonium salts that are not readily biodegradable shall not be used, either as part of the formulation or as part of any preparation included in the formulation.

Assessment and verification: the applicant shall provide documentation showing the biodegradability of any quaternary ammonium salt used.

(c) No ingredient (substance or preparation) shall be included in the product that is classified, with any of the following risk phrases, or any combination thereof, in accordance with Directive 67/548/EEC and its amendments or Directive 1999/45/EC of the European Parliament and of the Council(3) and its amendments:

• R31 (contact with acid liberates toxic gas),

• R40 (limited evidence of a carcinogenic effect),

• R45 (may cause cancer),

• R46 (may cause heritable genetic damage),

• R49 (may cause cancer by inhalation),

• R68 (possible risks of irreversible effects)

• R50-53 (very toxic to aquatic organism and may cause long term adverse effects in the aquatic environment),

• R51-53 (toxic to aquatic organism and may cause long term adverse effects in the aquatic environment),

• R59 (dangerous to the ozone layer),

• R60 (may impair fertility),

• R61 (may cause harm to the unborn child),

• R62 (possible risk of impaired fertility),

• R63 (possible risk of harm to the unborn child),

• R64 (may cause harm to breastfed babies).

Specific requirements are prescribed for biocides, either as part of the formulation or as part of any preparation included in the formulation (see criterion on biocides below).

The above requirements shall apply to each ingredient (substance or preparation) that exceeds 0,01 % by weight of the final product. This includes also each ingredient of any preparation used in the formulation that exceeds 0,01 % by weight of the final product.

Assessment and verification: copies of the material safety data sheets shall be provided for all ingredients (whether substances or preparations). A declaration prepared by the manufacturer of ingredients and showing compliance with this criterion shall be provided by the applicant.

4. Biocides

(a)

The product may only include biocides in order to preserve the product, and in the appropriate dosage for this purpose alone. This does not refer to surfactants, which may also have biocidal properties.

Assessment and verification: copies of the material safety data sheets of any preservatives added shall be provided, together with information on their exact concentration in the product. The manufacturer or supplier of the preservatives shall provide information on the dosage necessary to preserve the product.

(b)

It is prohibited to claim or suggest on the packaging or by any other communication that the product has an antimicrobial action.

Assessment and verification: the texts and layouts used on each type of packaging and/or an example of each different type of packaging shall be provided to the competent body.

Biocides, either as part of the formulation or as part of any preparation included in the formulation, that are used to preserve the product and that are classified with R50-53 or R51-53 risk phrases, in accordance with Directive 67/548/EEC and its amendments or Directive 1999/45/EC, are permitted but only if they are not potentially bioaccumulative. In this context, a biocide is considered to be potentially bioaccumulative if the log P_ow (log octanol/water partition coefficient) ≥3,0 (unless the experimentally determined BCF ≤100).

The concentration of biocides in the final product shall not exceed the maximum authorised concentration in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products and its subsequent amendments.

Assessment and verification: copies of the material safety data sheets shall be provided for all biocides, together with a documentation of the concentrations of the biocides in the final product.

5. Dyes or colouring agents

Any dyes or colouring agents used in the product must be permitted by Council Directive 76/768/EEC relating to cosmetic products(4) and its subsequent amendments, or must be permitted by European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs(5) and its subsequent amendments, or must be characterised by environmental properties that do not imply classification with R50-53 or R51-53 risk phrases, in accordance with Directive 67/548/EEC and its amendments.

Assessment and verification: a declaration of compliance with this criterion shall be provided to the competent body, together with a full list of all dyes or colouring agents used.

6. Fragrances

(a)

The product shall not contain perfumes containing nitro-musks or polycyclic musks (as specified in the criterion 3(a).

(b)

Any ingredients added to the product as a fragrance must have been manufactured and/or handled in accordance with the code of practice of the International Fragrance Association.

Assessment and verification: a declaration of compliance with each part of this criterion shall be provided to the competent body.

7. Sensitising substances

The product shall not be classified with R42 (may cause sensitisation by inhalation) and/or R43 (may cause sensitisation by skin contact) risk phrases, in accordance with Directive 1999/45/EC and its amendments.

The concentration of any substance or ingredient classified with R42 (may cause sensitisation by inhalation) and/or R43 (may cause sensitisation by skin contact) risk phrases, in accordance with Directive 67/548/EEC and its amendments or Directive 1999/45/EC and its amendments, shall not exceed 0,1 % by weight of the final product.

Assessment and verification: the exact concentrations of all ingredients that are classified as R42 and/or R43 shall be provided to the competent body, together with copies of the material safety data sheets.

8. Volatile organic compounds

The product shall not contain more than 10 % (by weight) of volatile organic compounds with a boiling point lower than 150 ^oC.

Assessment and verification: copies of the material safety data sheets of each organic solvent together with details of the calculations of the total volatile organic compounds with a boiling point lower than 150 ^oC shall be provided by the applicant.

9. Phosphorus

The total quantity of elemental phosphorous in the product shall be calculated per functional unit (for all-purpose cleaners) or per 100 g of product (cleaners for sanitary facilities) taking into account all ingredients containing phosphorus (e.g. phosphates and phosphonates).

For all-purpose cleaners, the total phosphorus content (P) shall not exceed 0,02 g/functional unit.

For cleaners for sanitary facilities, the total phosphorus content (P) shall not exceed 1,0 g/100 g of product.

Ingredients used in window cleaning products must not contain phosphorus.

Assessment and verification: the exact formulation of the product shall be provided to the competent body, together with the details of the calculations showing compliance with this criterion.

10. Packaging requirements

(a)

Sprays containing propellants must not be used.

(b)

Plastic materials that are used for the main container shall be marked according to European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste(6), or DIN 6120 Parts 1 and 2 in connection with DIN 7728 part 1.

(c)

If the primary packaging is made of recycled material, any indication of this on the packaging shall be in conformity with the ISO 14021 standard ‘Environmental labels and declarations — Self declared claims (type II environmental labelling)’.

(d)

The primary packaging parts shall be easily separable into mono-material parts.

Assessment and verification: data on the packaging, and/or a sample thereof if appropriate, shall be provided to the competent body, together with a declaration of compliance with each part of this criterion.

FITNESS FOR USE

11. Fitness for use

The product shall be fit for use, meeting the needs of the consumers.

The cleaning ability must be equivalent to or better than a market-leading or generic reference product (see Appendix III), approved by a competent body, as well as better than pure water.

For all-purpose cleaners and cleaning products for kitchens, only fat-removing effects must be documented. For sanitary cleaning products and window cleaners, both calcium and fat-removing effects must be documented.

Assessment and verification: the performance of the product must either be tested by:

• an adequate and justifiable laboratory test, or

• an adequate and justifiable consumer test.

Both tests must be carried out and reported within specified parameters as stated in the framework described in Appendix III.

CONSUMER INFORMATION

12. User instructions

(a) Dosage instructions

For all-purpose cleaners, an exact dosage recommendation shall appear on the packaging in a reasonably sufficient size and against a visible background. The use of a pictogram (such as a 5 1 tub and number of caps with ml) is recommended but voluntary.

In the case of a concentrated cleaner for sanitary facilities, it shall be clearly indicated on the packaging that only a small quantity of the product is needed compared to normal (i.e. diluted) products.

The following text (or equivalent text) shall appear on the packaging:

‘Proper dosage saves costs and minimises environmental impacts’.

(b) Safety advice

The following safety advice (or equivalent text) shall appear on the product (in both text form and with an equivalent pictogram):

‘Keep away from children’

‘Do not mix different cleaners’

‘Avoid inhaling sprayed product’ (only for products that are packaged as sprays).

(c) Information and labelling of ingredients

Regulation (EC) No 648/2004 shall be applied.

(d) Information about the eco-label

The following text (or equivalent text) shall appear on the packaging:

‘For more information visit the EU eco-label web-site: http://europa.eu.int/ecolabel’.

Assessment and verification: a sample of the product packaging, including the label, shall be provided to the competent body, together with a declaration of compliance with each part of this criterion.

13. Information appearing on the eco-label

Box 2 of the eco-label shall contain the following text:

• reduced impact on aquatic life,

• reduced use of hazardous substances,

• clear user instructions.

14. Professional training

For detergents, which are used by professional users, the producer, its distributor or a third party shall offer training or training materials for cleaning staff. These shall include step-by-step instructions for proper dilution, use, disposal and the use of equipment.

Assessment and verification: a sample of training material containing step-by-step instructions for proper dilution, use, disposal and the use of equipment and a description of training courses shall be provided to the competent body.

(1)

OJ L 104, 8.4.2004, p. 13.

(2)

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1).

(3)

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1).

(4)

OJ L 262, 27.9.1976, p. 169.

(5)

OJ L 237, 10.9.1994, p. 13.

(6)

OJ L 365, 31.12.1994, p. 10.